Study of NGR-hTNF in Combination With Doxorubicin in Patients Affected by Metastatic Small Cell Lung Carcinoma (NGR007)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MolMed S.p.A.
ClinicalTrials.gov Identifier:
NCT00483509
First received: June 6, 2007
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic SCLC patients affected by advanced or metastatic small cell lung carcinoma (SCLC) previously treated with at least one therapeutic regimen


Condition Intervention Phase
Small Cell Lung Cancer
Drug: NGR-hTNF
Drug: Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NGR007: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Small Cell Lung Carcinoma (SCLC) Previously Treated With at Least One Therapeutic Regimen

Resource links provided by NLM:


Further study details as provided by MolMed S.p.A.:

Primary Outcome Measures:
  • Antitumour activity defined as progression free survival (PFS) [ Time Frame: during the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor Growth Control Rate (TGCR) [ Time Frame: during the trial ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: during the treatment and during the follow-up ] [ Designated as safety issue: No ]
  • Experimental Imaging Study (DCE-MRI) [ Time Frame: during the study ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: During the treatment and during the follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: December 2006
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NGR-hTNF
iv q3W 0.8 mcg/sqm NGR-hTNF
Drug: Doxorubicin
iv q3W 75 mg/sqm doxorubicin 60 minutes after NGR-hTNF infusion

Detailed Description:

This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic SCLC, previously treated with at the least one therapeutic regimen, that will be conducted using Simon's two-stage design method.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years affected by SCLC previously treated with at least one therapeutic regimen (including doxorubicin). However, in case of patient already pretreated with doxorubicin, a previous cumulative dose of doxorubicin < 300 mg/m^2 is recommended and the current treatment has to be stopped when a maximum cumulative dose of doxorubicin 550 mg/m^2 is reached.
  • Cytology or histology confirmed SCLC at first diagnosis (patient with recurrent disease do not require a confirmatory biopsy to be eligible)
  • Measurable disease, defined as ≥ 1 unidimensional measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by CT scan according to RECIST criteria
  • ECOG Performance status 0 - 2
  • Adequate baseline bone marrow, hepatic and renal function, defined as follows:

    • Neutrophils > 1.5 x 10^9/L and platelets > 100 x 10^9/L
    • Bilirubin < 1.5 x ULN
    • AST and/or ALT < 2.5 x ULN in absence of liver metastasis
    • AST and/or ALT < 5 x ULN in presence of liver metastasis
    • Serum creatinine < 1.5 x ULN
  • Absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (reference appendix "Technical data sheet human albumin")
  • Normal cardiac function (LVEF ≥ 55%) and absence of uncontrolled hypertension
  • Patients may have had prior therapy providing the following conditions are met:

    - Chemotherapy, radiation therapy, hormonal therapy or immunotherapy: wash-out period of 28 days before start treatment

    - Surgery: wash-out period of 14 days before start treatment

  • Patients must give written informed consent to participate in the study

Exclusion Criteria:

  • Concurrent anticancer therapy
  • Patients may not receive any other investigational agents while on study
  • Patients with myocardial infarction within the last six (6) months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
  • Uncontrolled hypertension
  • Prolonged QTc interval (congenital or acquired)
  • Patient with significant peripheral vascular disease
  • Previous signs of cardiotoxicity doxorubicin related
  • Clinical signs of CNS involvement
  • Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
  • Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients
  • Known hypersensitivity/allergic reaction or contraindications to anthracyclines
  • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
  • Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483509

Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Turin, Italy, 10043
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Azienda Ospedaliera Universitaria San Martino
Genoa, Italy, 16132
Fondazione San Raffaele del Monte Tabor
Milan, Italy, 20132
Sponsors and Collaborators
MolMed S.p.A.
Investigators
Study Director: Antonio Lambiase, MD MolMed S.p.A.
  More Information

No publications provided

Responsible Party: MolMed S.p.A.
ClinicalTrials.gov Identifier: NCT00483509     History of Changes
Other Study ID Numbers: NGR007, 2006-005700-14
Study First Received: June 6, 2007
Last Updated: January 28, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by MolMed S.p.A.:
NGR-hTNF
SCLC

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014